Tool development

Proof of concept

In 2015, we conducted a proof of concept using an earlier version of this writing tool in a split-manuscript randomised controlled trial (RCT). We evaluated its effect on the completeness of reporting of randomised controlled trials (RCTs). Forty-one students were randomly assigned to different real RCT protocols and asked to write six domains of the methods section of the manuscript for the protocol they received over a four-hour period.

The tool provided, for each domain, reminders of the relevant CONSORT items, bullet points highlighting the key elements to report, and examples of good reporting. The control group received no reminders. Results revealed a large effect of the writing tool on the completeness of reporting. We demonstrated that a writing aid tool can improve the completeness of reporting and that we need to rethink the strategies used to implement CONSORT. The expansion of the tool was recommended to cover all CONSORT items and incorporate all extensions.

In 2016, we evaluated the impact of WebCONSORT, a simple web-based tool incorporating the main CONSORT checklist and variousCONSORT extensions, on the completeness of reporting of randomised trials published in biomedical journals. WebCONSORT enabled authors to obtain a customized CONSORT checklist and flow diagram specific to their trial design and type of intervention. The study concluded on the need for better education much earlier in the publication process for authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions. It may be more effective to focus on a core set of CONSORT items with more detailed information on how to implement each item within the context of a specific trial, the authors concluded.

Content of the tool

The tool includes several personalized templates designed to reflect the CONSORT reporting recommendations for different study designs, types of interventions, and medical conditions.

For each template, we summarized and integrated guidance from the main CONSORT 2010 Statement and its Explanation and Elaboration, as well as from the following key extensions:

For example, when applied to surgical trials, the tool provides bullet points tailored to surgical procedures and includes examples drawn from surgical research.

Similarly, for oncology studies, it incorporates specific recommendations related to systemic cancer therapies and radiotherapy.

We are currently updating the templates to align with the forthcoming CONSORT 2025 recommendations.

The updated version of the tool will continue to offer personalized templates adapted to different study designs, intervention types, and medical conditions, integrating guidance from: